Package leaflet: Information for the user
Finasterid Actavis 5 mg film coated tablets
Finasteride
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1.
What Finasterid Actavis is and what it is used for
2.
What you need to know before you take Finasterid Actavis
3.
How to take Finasterid Actavis
4.
Possible side effects
5.
How to store Finasterid Actavis
6.
Contents of the pack and other information
1.
What Finasterid Actavis is and what it is used for
Finasterid Actavis contains the active substance finasteride which belongs to a group of medicines
called ‘5-alpha reductase inhibitors’. They act by reducing the size of the prostate gland in men.
Finasterid Actavis is used in the treatment and control of benign (not cancerous) enlargement of the
prostate.
2.
What you need to know before you take Finasterid Actavis
Do not take Finasterid Actavis:
if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section
6).
if you are a woman or a child (see also ‘Pregnancy and breast-feeding’ in this section).
Warnings and precautions
Talk to your doctor or pharmacist before taking Finasterid Actavis
if you have reduced liver function.
if you have difficulty emptying your bladder completely or a greatly reduced flow of urine, your
doctor should examine you thoroughly before you start taking Finasterid Actavis to exclude
other obstructions in the urinary tract.
if you notice any changes in your breast tissue such as lumps, pain, enlargement of the breast
tissue or nipple discharge as these may be signs of a serious condition, such as breast cancer.
You should promptly report to your doctor if you notice any of these changes.
If your sexual partner is or may potentially be pregnant, you should avoid exposing her to your semen
which could contain a tiny amount of the drug (see also ‘Pregnancy and breast-feeding’ in this
section).
If you need to have a blood test called “PSA”, make sure you tell your doctor or nurse first since
finasteride may alter the results of the test.
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Other medicines and Finasterid Actavis
Finasterid Actavis tablets can normally be taken with other medicines. Please ask your doctor before
you take other medicines at the same time.
Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines.
Finasterid Actavis with food and drink
Finasterid Actavis can be taken with or without food.
Pregnancy and breast-feeding
Finasterid Actavis is only intended for men.
If your sexual partner is or may potentially be pregnant, you should avoid exposing her to your semen
which could contain a tiny amount of the drug.
Women who are pregnant or may become pregnant should not handle broken or crushed
Finasterid Actavis tablets. If finasteride is absorbed through the skin or taken by mouth by a woman
pregnant with a male fetus, the child may be born with malformed genital organs. The tablets are filmcoated, which prevents contact with finasteride provided the tablets are not broken or crushed.
Driving and using machines
There is no evidence to suggest that Finasterid Actavis affects the ability to drive or use machines.
Finasterid Actavis contains lactose
Finasterid ActavisIf you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
3.
How to take Finasterid Actavis
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
The recommended dose is 1 tablet daily.
The tablet should be swallowed whole and should not be broken or crushed. It may be taken with or
without food.
If you take more Finasterid Actavis than you should
Immediately contact a doctor, the nearest hospital casualty department or the centre for poison
information for advice.
If you forget to take Finasterid Actavis
Do not take a double dose to make up for a forgotten tablet. Just take the next one when it is due.
If you stop taking Finasterid Actavis
Although an improvement is often noticed after a short time, it may be necessary to continue the
treatment for at least 6 months. Do not alter the dose or stop treatment without asking your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Finasterid Actavis and immediately contact your doctor if you experience any of the
following symptoms (angioedema): Swelling of the face, tongue or throat; difficulty swallowing; hives
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and breathing difficulties. These symptoms can be signs of an allergic reaction, which is reported as
not known (frequency cannot be estimated from the available data).
Common (affects 1 to 10 users in 100):
Inability to obtain an erection, reduced sex drive, reduced ejaculatory volume.
Uncommon (affects 1 to 10 users in 1,000):
Tenderness of the breasts, skin rash, breast enlargement, difficulty obtaining ejaculation.
Not known (frequency cannot be estimated from the available data):
Depression, testicular pain, Inability to obtain an erection even after stopping treatment with Finasterid
Actavis, reduced sex drive that continued after stopping treatment, male infertility and/or poor quality
of semen, itching, urticaria (hives), irregular, hard, or rapid heartbeat, increase in liver enzymes.
You should promptly report to your doctor any changes in your breast tissue such as lumps, pain,
enlargement of the breast tissue or nipple discharge as these may be signs of a serious condition, such
as breast cancer.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of
this medicine.
5.
How to store Finasterid Actavis
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP.’: The
expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What Finasterid Actavis contains
The active substance (the ingredient which makes the medicine work) is finasteride. One filmcoated tablet contains 5 mg finasteride.
The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose,
pregelatinised starch (maize), lauroyl macrogolglycerides, sodium starch glycolate, magnesium
stearate. The tablet coating contains hypromellose, macrogol, titanium dioxide (E171) and
indigo carmine aluminium lake (E132).
What Finasterid Actavis looks like and contents of the pack
Finasterid Actavis is a blue, round, biconvex tablet marked "F5". The diameter is 7 mm.
Blister packs containing 7, 10, 14, 15, 20, 28, 30, 49, 50, 60, 98, 100 or 300 tablets.
Plastic bottles containing 10, 30, 50, 100 or 300 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Actavis Nordic A/S
3
Ørnegårdsvej 16
DK-2820 Gentofte
Denmark
<[To be completed nationally]>
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Manufacturer
Actavis hf.
Reykjavikurvegur 78
IS-220 Hafnarfjördur
Iceland.
This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria
Denmark
Italy
Norway
Portugal
Sweden
Finasterid Actavis 5 mg Filmtabletten
Finasterid Actavis
Finasterid Actavis 5 mg
Finasterid Actavis
Finasterida Aurovitas
Finasterid Actavis
This leaflet was last approved in 2015-07-23.
<[To be completed nationally]>
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